TITLE 26 FOOD, DRUGS, AND COSMETICS

Section 4. Pharmacists and Pharmacies, 26-4-1 through 26-4-214.

ARTICLE 6 PHARMACIES

26-4-115. Wholesale drug distributors; registration; fees; reports of excessive purchases; penalty for violations; transfers of drugs.

1. All persons, firms, or corporations, whether located in this state or in any other state, engaged in the business of selling or distributing drugs at wholesale in this state, in the business of supplying drugs to manufacturers, compounders, and processors in this state, or in the business of a reverse drug distributor shall biennially register with the board as a drug wholesaler, distributor, reverse drug distributor, supplier, outsourcing facility, or third-party logistics provider; provided, however, that out-of-state firms that conduct intracompany transfers of drugs to and have the same ownership as a licensed firm in this state shall not be required to register pursuant to this subsection; and provided, further, that out-of-state third-party logistics providers that are licensed by their resident state or by the federal Food and Drug Administration shall not be required to register pursuant to this subsection. The application for registration shall be made on a form to be prescribed and furnished by the board and shall show each place of business of the applicant for registration, together with such other information as may be required by the board. The application shall be accompanied by a fee in an amount established by the board for each place of business registered by the applicant. Such registration shall not be transferable and shall expire on the expiration date established by the executive director. Registration shall be renewed pursuant to the rules and regulations of the board, and a renewal fee prescribed by the board shall be required. If not renewed, the registration shall lapse and become null and void. Registrants shall be subject to such rules and regulations with respect to sanitation or equipment as the board may, from time to time, adopt for the protection of the public health and safety. Such registration may be suspended or revoked or the registrant may be reprimanded, fined, or placed on probation by the board if the registrant fails to comply with any law of this state, the United States, or any other state having to do with the control of pharmacists, pharmacies, wholesale distribution, reverse drug distribution, or outsourcing facility distribution of controlled substances or dangerous drugs as defined in Chapter 13 of Title 16; if the registrant fails to comply with any rule or regulation promulgated by the board; or if any registration or license issued to the registrant under the federal act is suspended or revoked.
2. Every drug wholesaler, distributor, supplier, or outsourcing facility registered as provided in Chapter 13 of Title 16 or in subsection (a) of this Code section, except reverse drug distributors, shall:
   1. Submit reports, upon request from the Georgia Drugs and Narcotics Agency, to account for all transactions with licensed persons or firms located within this state; such reportable transactions shall include all dangerous drugs and controlled substances as defined in Chapter 13 of Title 16. Such reports shall be submitted to the Georgia Drugs and Narcotics Agency;
   2. Automatically submit reports of any excessive purchases of controlled substances by licensed persons or firms located within this state using the federal Drug Enforcement Administration guidelines to define excessive purchases as set forth under the provisions of 21 C.F.R. Section 1301. Such reports shall be submitted to the Georgia Drugs and Narcotics Agency; and
   3. 1. Comply with the requirements of Section 360eee, et seq., of the federal act, relating to drug supply chain security.
      2. Each manufacturer of a drug subject to Section 360eee, et seq., of the federal act shall maintain at its corporate offices a current list of the authorized wholesale distributors of such drug.
      3. The board shall establish rules and regulations relating to drug supply chain security based on the requirements of Section 360eee, et seq., of the federal act which are not inconsistent with, more stringent than, or in addition to any requirements applicable under Section 353(e) or Section 360eee of the federal act or any regulations issued thereunder and which are not inconsistent with any waiver, exception, or exemption pursuant to Section 360eee, et seq., of the federal act or any restrictions specified in Section 360eee-1 of the federal act.
3. The board shall be authorized to promulgate rules and regulations to facilitate compliance with this Code section. Such rules and regulations shall include a requirement that all wholesale drug distributors required to register pursuant to this Code section shall make adequate provision for the return of outdated drugs, both full and partial containers, for up to six months after the labeled expiration date for prompt full credit or replacement; provided, however, that such rules and regulations may also include a list of drugs exempted from the requirements of such provision that have been determined by the board as essential to health care treatment and having an expiration date of less than one year from the date such drug is manufactured.
4. The provisions of subsection (b) of this Code section shall not apply to any wholesaler, manufacturer, distributor, or supplier that only ships controlled substances directly to a licensed wholesaler within this state.
5. Any person, firm, or corporation which violates any provision of this Code section shall be guilty of a felony and, upon conviction thereof, shall be punished by imprisonment for not less than one year nor more than five years or by a fine not to exceed $25,000.00, or both.
6. Any practitioner who knowingly transfers any controlled substance or dangerous drug as such terms are defined in Chapter 13 of Title 16 by purchasing from or returning to a person, firm, or corporation which is not registered as required in subsection (a) of this Code section or as required in Chapter 13 of Title 16 shall be guilty of a felony and, upon conviction thereof, shall be punished by imprisonment for not less than one year nor more than three years or by a fine not to exceed $10,000.00, or both.
7. Transfers of drugs from a licensed hospital pharmacy to an entity that is affiliated with or owned by the hospital shall not be deemed wholesale distributors of drugs.

(Code 1981, §26-4-115, enacted by Ga. L. 1998, p. 686, § 1; Ga. L. 2000, p. 1706, § 19; Ga. L. 2002, p. 1492, § 3; Ga. L. 2013, p. 192, § 1-17/HB 132; Ga. L. 2016, p. 855, § 6/HB 926; Ga. L. 2017, p. 417, § 8-1/SB 104.)

The 2013 amendment, effective July 1, 2013, in subsection (a), substituted "the board" for "said board" in the second sentence, and substituted "executive director" for "division director" in the fourth sentence.

The 2016 amendment, effective July 1, 2016, in subsection (a), in the first sentence, near the end, deleted "or" preceding "supplier", and added the language beginning with ", outsourcing facility, or" and ending with "pursuant to this subsection", in the last sentence, substituted "reverse drug distribution, or outsourcing facility distribution" for "or reverse drug distribution" in the middle; substituted "distributor, supplier, or outsourcing facility registered" for "distributor, or supplier registered" in the introductory paragraph of subsection (b); deleted "and" at the end of paragraph (b)(1); in paragraph (b)(2), in the first sentence, substituted "excessive purchases" for "'excessive purchases'", and substituted "Section 1301" for "Sec. 1301", and, in the second sentence, substituted "; and" for a period at the end; added paragraph (b)(3); added the proviso at the end of subsection (c); and substituted "supplier that" for "supplier who" in subsection (d).

The 2017 amendment, effective May 8, 2017, added subsection (g).